Yoga and Brain Cancer: A Feasibility Study
I. To estimate the participation rate, accrual, adherence, and retention to a yoga trial in
patients with malignant brain tumors.
I. To obtain estimates of the variability of self-reported fatigue, distress (i.e.,
depression, anxiety), sleep disturbance, cognitive function, and health-related quality of
life from baseline to the end of the intervention at 6 (post-onsite intervention) and 12
weeks (post-full intervention).
II. To obtain preliminary estimates of the efficacy of a yoga intervention in patients with
malignant brain tumors on the outcomes of fatigue, distress, and cognitive function.
III. To standardize the cancer-specific yoga protocol for use with brain tumor patients.
Patients participate in yoga classes comprising postures, deep relaxation, breathing
practices, and meditation twice weekly for 75 minutes during weeks 1-6. Patients then
practice yoga at home twice weekly for 45 minutes during weeks 7-12.
After completion of study treatment, patients are followed up periodically for 4-5 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Estimate the participation rate, accrual, adherence, and retention to a yoga trial in patients with malignant brain tumors
Track barriers to recruitment. Participation rate calculated as proportion of eligible patients who agree to participate. Study retention estimated as proportion of participating patients who complete questionnaires at Week 6. Further retention data obtained by tracking # of dropouts, when dropout occurs, & reasons for dropout. Intervention adherence estimated as mean % of yoga classes attended. Summary statistics for patient characteristics, participation rates, adherence & retention. 95% confidence intervals calculated for each feasibility measure.
Up to 12 weeks
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Comprehensive Cancer Center of Wake Forest University||Winston-Salem, North Carolina 27157-1082|